Sugammadex, the anesthesia-reversal drug at the center of a long and to-date fruitless battle for FDA approval, appears finally be on the verge of acceptance.

An independent panel of regulators says Merck & Co., has satisfactorily addressed previously raised concerns about the risks of hypersensitivity/anaphylaxis and cardiac dysrhythmias and unanimously recommended approval. The final hurdle has yet to be cleared, however. The FDA, which is expected to make a decision by Dec. 19, isn't bound by the committee's recommendation.

The drug, which is marketed in 70 other countries as Bridion, reverses the muscle-relaxing effects of rocuronium and vecuronium. It was first rejected by the FDA in 2008, a year before Merck merged with Schering-Plough and acquired the drug. Merck's quest for approval failed again both in 2013 and earlier this year.

Jim Burger